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Company Name Brand Name GMDN Term Name GMDN Term Status FDA Product Code Name FDA Product Code Device Packaged As Sterile Sterilization Prior To Use Issuing Agency Device Size Device Size Type Device Class Implantable

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Software to identify heart failure patients who may be at risk of having wtATTR-CM
PFIZER INC.
CI4054279
In Commercial Distribution

  • 05415062388310 ()


  • Cardiovascular interpretive screening software
No Description
THE MAGSTIM COMPANY LIMITED
6251-00
In Commercial Distribution

  • 05060229533081 ()


  • Clinical management support software
No Description
THE MAGSTIM COMPANY LIMITED
6261-00
In Commercial Distribution

  • 05060229533074 ()


  • Clinical management support software
No Description
THE MAGSTIM COMPANY LIMITED
5736-00
In Commercial Distribution

  • 05060229532794 ()


  • Clinical management support software
No Description
THE MAGSTIM COMPANY LIMITED
5453-00
In Commercial Distribution

  • 05060229532725 ()


  • Clinical management support software
AI4CMR v1.0 is a cloud-hosted service used with any third-party DICOM viewer applicationwhere the DICOM viewer serves as the user interface and the interface to a PACS or scanner forAI4CMR. AI4CMR is implemented as a plug-in to the DICOM viewer by the user andautomatically processes and analyses cardiac MR images received by the DICOM viewer toquantify relevant cardiac function metrics and makes the information available to the user at theuser’s discretion Indications for use: AI4CMR software is designed to report cardiac function measurements (ventricle volumes, ejection fraction, indices etc.) from 1.5T and 3T magnetic resonance (MR) scanners. AI4CMR uses artificial intelligence to automatically segment and quantify the different cardiac measurements. Its results are not intended to be used on a stand-alone basis for clinical decision-making. The user incorporating AI4CMR into their DICOM application of choice is responsible for implementing a user interface.
AI4MEDIMAGING - MEDICAL SOLUTIONS, S.A.
v1.0
In Commercial Distribution

  • 05600250059022 ()


  • MRI system application software
ORTHO CONNECT™ Software is designed to collect data from the Ortho Clinical Diagnostics blood typing instruments and its proprietary immunohematology reagent system, which allows operators to track individual patient and donor samples and link them to the appropriate test results. The software collates the results from testing, assigns outcomes to individual samples according to configured rules, and formats output files that can be sent to a Laboratory Information Management System (LIMS). ORTHO CONNECT™ Software is intended to be used by Blood Establishments and by personnel who are trained in its operation.
BIOMEDICAL DATA SOLUTIONS LIMITED
3.0
In Commercial Distribution

  • 05060496770066 ()


  • Laboratory instrument/analyser application software IVD
No Description
VINEHEALTH DIGITAL LIMITED
R1 V3
In Commercial Distribution

  • 05070000764122 ()


  • Clinical management support software
NUCLeUS OR Controller
SONY CORPORATION
NU-MC30E
In Commercial Distribution

  • 04548736120679 ()


  • Operating room audiovisual data/device management system application software
Network System Manager
SONY CORPORATION
NU-NM30E
In Commercial Distribution

  • 04548736106291 ()


  • Operating room audiovisual data/device management system application software
No Description
KONAN MEDICAL, INC.
CellChek 20-1 PLUS
In Commercial Distribution

  • 04582275250671 ()


  • Eye anterior segment analyser
No Description
KONAN MEDICAL, INC.
CellChek 20-1
In Commercial Distribution

  • 04582275250664 ()


  • Eye anterior segment analyser
No Description
KONAN MEDICAL, INC.
CC 20 rc
Not in Commercial Distribution

  • 04582275250657 ()


  • Eye anterior segment analyser
No Description
KONAN MEDICAL, INC.
CellChek 20
In Commercial Distribution

  • 04582275250626 ()


  • Eye anterior segment analyser
No Description
KONAN MEDICAL, INC.
NSPC
Not in Commercial Distribution

  • 04582275250374 ()


  • Eye anterior segment analyser
No Description
KONAN MEDICAL, INC.
NSP
Not in Commercial Distribution

  • 04582275250107 ()


  • Eye anterior segment analyser
No Description
TOPCON CORPORATION
SP-1P
In Commercial Distribution

  • 04562123288315 ()


  • Eye anterior segment analyser
ScanNav Anatomy Peripheral Nerve Block (Anatomy PNB) is a software as a medical device (SaMD) which assists qualified healthcare professionals to identify anatomy in live ultrasound images. The Anatomy PNB receives scan images in real-time from a compatible general-purpose ultrasound machine. It then processes the images using deep learning artificial intelligence algorithms and highlights relevant anatomical structures on the Anatomy PNB user interface. The original view from the ultrasound machine is not affected and is always available both on the ultrasound machine and the Anatomy PNB.
INTELLIGENT ULTRASOUND LIMITED
V2.0
Not in Commercial Distribution

  • 05060878810052 ()


  • Ultrasound imaging system application software
ScanNav Anatomy Peripheral Nerve Block (Anatomy PNB) is a software as a medical device (SaMD) which assists qualified healthcare professionals to identify anatomy in live ultrasound images. The Anatomy PNB receives scan images in real-time from a compatible general-purpose ultrasound machine. It then processes the images using deep learning artificial intelligence algorithms and highlights relevant anatomical structures on the Anatomy PNB user interface. The original view from the ultrasound machine is not affected and is always available both on the ultrasound machine and the Anatomy PNB.
INTELLIGENT ULTRASOUND LIMITED
V1.1
Not in Commercial Distribution

  • 05060878810021 ()


  • Ultrasound imaging system application software
iLet Bionic Pancreas (Pharmacy Starter Kit)
Beta Bionics, Inc.
Insulin Only
In Commercial Distribution

  • 00850050080206 ()
BB1004

  • Ambulatory insulin infusion pump/interstitial glucose monitoring system
iLet Bionic Pancreas (Government Starter Kit)
Beta Bionics, Inc.
Insulin Only
In Commercial Distribution

  • 00850050080190 ()
BB1003

  • Ambulatory insulin infusion pump/interstitial glucose monitoring system
iLet Bionic Pancreas (Commercial Starter Kit)
Beta Bionics, Inc.
Insulin Only
In Commercial Distribution

  • 00850050080183 ()
BB1002

  • Ambulatory insulin infusion pump/interstitial glucose monitoring system
iLet Bionic Pancreas (Commercial Starter Kit)
Beta Bionics, Inc.
Insulin Only
In Commercial Distribution

  • 00850050080046 ()
BB1002

  • Ambulatory insulin infusion pump/interstitial glucose monitoring system
iLet Bionic Pancreas (Government Starter Kit)
Beta Bionics, Inc.
Insulin Only
In Commercial Distribution

  • 00850050080039 ()
BB1003

  • Ambulatory insulin infusion pump/interstitial glucose monitoring system
iLet Bionic Pancreas (Pharmacy Starter Kit)
Beta Bionics, Inc.
Insulin Only
In Commercial Distribution

  • 00850050080022 ()
BB1004

  • Ambulatory insulin infusion pump/interstitial glucose monitoring system
No Description
SHANGHAI MEDIWORKS PRECISION INSTRUMENTS CO.,LTD.
Scansys TA517
In Commercial Distribution

  • 06945087505175 ()


  • Eye anterior segment analyser
MR-RT is an add-on to the existing Ingenia 1.5T and 3.0T MR systems that makes the system suitable for MR imaging for radiation therapy planning purposes. MR-RT consists of RTGo SW and MR CouchTop accessory. RTgo is a software that provides MR-RT functionality including MRCAT (MRCAT Prostate, MRCAT Pelvis, MRCAT Brain, MRCAT Head &Neck)
Philips Oy
RTgo 5.0 5
Not in Commercial Distribution

  • 00884838107311 ()
300005806302

  • MRI system application software
UroNav is a medical image processing device that provides image-guided intervention and diagnostic information, which guides interventional instrumentation to targets that have been defined by the physician.
Philips DS North America LLC
UroNav 4
In Commercial Distribution

  • 00884838107069 ()
784039

  • Ultrasound imaging system application software
MR-RT is an add-on to the existing Ingenia 1.5T and 3.0T MR systems that makes the system suitable for MR imaging for radiation therapy planning purposes. MR-RT consists of RTGo SW and MR CouchTop accessory. RTgo is a software that provides MR-RT functionality including MRCAT (MRCAT Prostate, MRCAT Pelvis, MRCAT Brain)
Philips Oy
MRCAT Brain / RTgo 4.1
In Commercial Distribution

  • 00884838098206 ()
781439

  • MRI system application software
DynaCAD is a MR image analysis software medical device that consists of MR Analysis Server, Viewer application, and Interventional Planning application.
Philips DS North America LLC
5
In Commercial Distribution

  • 00884838094857 ()
4598-016-98182, 3000-103-14352, 300011916421

  • MRI system application software
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